Contraceptive device

ABSTRACT

The present invention relates to a contraceptive device to be placed both in the uterine cavity and in the uterine neck and comprising on the one hand a hollow cylinder provided with one or more windows on its side wall and with a widening at its upper part and, housed in said tube by one of their ends, on the one hand two curved stems and a stem folded back on itself forming a loop, the summit of the loop being provided with an excrescence.

O United States Patent 1 r 3,734,089 Gaud 1 May 22, 1973 [54]CONTRACEPTIVE DEVICE 3,364,927 1/1968 Robinson ..l28/l30 [76] QInventor: 2:22; gi i gfi inifg s: Primary Examiner-Richard A. GaudetFrance y Assistant Examiner-G. F. Dunne: Attorney-Lorimer P. Books eta]. [22] Filed: Dec. 14, 1971 21 Appl. No.: 207,768 ABSTRACT The presentinvention relates to a contraceptive [30] Foreign Appli ation Priorit Dt device to be placed both in the uterine cavity and in i the uterineneck and comprising on the one hand a Dec. 15,1970 France ..7045235hollow cylinder provided with one or more windows 52 us. Cl ..128/130128/260 its side wall and with a widening at its upper 51 int. Cl...A6lt 5/46 hOhsed in said by one Of their ends, the 58 Field of Search..128/127, 128, 179, one hand Curved Stems and Stem famed back 12 1 1260, 261 itself forming a loop, the summit of the loop being providedwith an excrescence. [56] References Cited 6 Claims, 3 Drawing; FiguresUNITED STATES PATENTS 559,406 5/1896 Ryman ..128/13l CONTRACEPTIVEDEVICE The present invention relates to an intra-uterine contraceptivedevice to be placed without pain both in the uterine cavity and the neckof the uterus.

The positioning by a doctor of a contraceptive device for intra-uterineuse has regained favor and is more extensive, after the recentcontroversy concerning the taking of oral contraceptives.

In the field of intra-uterine devices, the use of rings and coiled,looped" or arcuate devices is recommended in particular for reducing therate of pregnancy. Now, in certain cases, the heretofore known devicesproved to be defective either in that the woman became pregnantunwillingly, the organism could not tolerate said devices, or finally inthat said devices were expelled in view of the contractions andperistaltic muscular phenomena produced and of the degree of contractionof the opening of the neck of the uterus.

In order to obviate the above-mentioned disadvantages, a novel device isproposed which acts both on the wall of the uterine cavity and thecervical wall, the part of said device which acts at the level of theuterine cavity not being flat as in the prior art.

BODY OF THE INVENTION The device according to the invention, whichcomprises a pair of supple, curved stems located in the same plane, theupper ends of which are folded back, in opposite directions, and asupple stem folded back on itself forming a loop, the assembly of saidstems being intended to be disposed inside the uterine cavity, ischaracterized in that said pair of stems, the loop and a second pair ofstems similar to the first pair, but angularly shifted with respectthereto, are housed, by means of their lower ends, inside a hollowcylindrical tube intended to be placed inside the neck of the uterus,which tube is widened at its. upper end and is provided with one or morewindows on its side wall, the pairs of stems and the loop being inplanes parallel to the axis of said tube, and in that the loop isprovided at its summit with an excrescence which is substantiallyperpendicular to the plane of said loop.

The assembly constituted by the loop and the two pairs of stems isintended to occupy the greater part of the space of the uterine cavity.These stems are preformed in such a manner that they are deformablerectilinearly by the application of a force, in order to enable thedoctor to place and remove the device according to the invention.

By the combination of the loop and the two pairs of stems, a device isproduced, the part of which that is intended to act at the level of theuterine cavity, is in the form of a lily.

The tubular cylinder is intended to permit the menstrual flow of blood.The widened form of the end where the stems are assembled is placed atthe level of the uterine isthmus. This widening is preferably oval orelliptic in section, so that the isthmic region is not obturated, butfavors the flow towards the neck. The hollow tube is also preferablyoval or elliptic in order to ensure said flow.

In the side wall of the tubular cylinder there are arranged at least twowindows, and preferably three, depending on the dimensions of theintra-uterine devices, as will be seen later. It is an object of thesewindows and the shape of the section of the hollow tube to avoid excesspressures inside said tube which would favor the ejection of the device,since the loop and the pairs of stems forming the lily would penetrateinto the cylindrical tube and would no longer ensure its holding in theneck.

The tubular cylinder disposed in the cervical region creates a zone ofdiffusion of acidity at the level of the cervical glair, rendering itspermifugal. It is known that the spermatozoa flee from acidity,particularly that of the vagina, and rise in the neck where they meet analkaline medium. Due to the presence of a hollow cylindrical tubeprovided with two or three windows, held in the neck, the cervical glairbecomes acid and remains impassable to the spermatozoa.

According to a characteristic of the invention, the hollow tube isprovided with an acid cream or jelly, with a pH of about 4.5 5introduced through the base of the tube, in order to encourage thediffusion of acid ity at the level of the cervical glair. The mostsuitable spermicidal jellies and creams that may be used are those whichcomply with the control criteria of the International Planned ParenthoodFederation. By way of non-limiting example, mention may be made of aspeciality based on nonylalkyl-phenoxyethanol and of lauryl and sodiumsulphate, commercialized by Laboratoires Labaz under the name ofDogynol, the pH of which being five. The acid cream is generallyintroduced through the lower aperture of the cylindrical tube and theacidity must be checked every 4 or 6 months in order to determine themoment of replacement. This check can be effected by means of a pHindicator paper.

According to another characteristic of the invention, each of the stemsof the pairs of stems is integral with a side part of the loop. In thiscase, the loop and said pair of stems are preferably located in the sameplane,

.which is parallel to the axis of the hollow tube.

The excrescence provided at the summit of the loop may be spherical orpreferably cylindrical. When said excrescence is a cylinder, the face:of the upper section of said cylinder is provided with a groove so as torender the contraceptive device more supple.

When, inside the uterine cavity, tensions are exerted on the excrescenceof a loop integral with a pair of stems, the assembly does not returninto the hollow tube; on the contrary, said pair of stems prevents theexpulsion since the stems abut more strongly on the walls of the uterinecavity.

Such a device, due to its lily shape, avoids having to fix the hollowtube to the edge of the neck of the uterus by one or more stitches.However, in order to render the device according to the invention moreintegral with the womans internal organs, there may be provided a fixingmeans integral with the hollow tube on which possible stitches will bemade.

This fixing means may, according to a particular embodiment of theinvention, be a tongue-shaped member provided at the lower end of thehollow tube, in the form of an arc, and intended to cover the edge ofthe uterine neck as far as the stitch. According to another embodiment,this fixing means may be a pastille or excrescence provided on the outerwall of the hollow tube at the lower end thereof, the stitches thenbeing effected if necessary on the inner edge of the opening of theneck. This latter mode of fixation has two advantages: for the doctor,it is much more practical to make the stitches at the level of the inneredge of the opening of the neck than to make them on the outer edge ofsaid opening, on the one hand, and, on the other hand, such a mode offixation enables the dimensions of the fixing means to be reduced.

The material used for making the device according to the invention isgenerally a synthetic macromolecular substance chosen in particular frompolyamides, polyesters, polyfluoroalkylenes and polyolefins which do notirritate the tissues and have a high resistance to the attack of theenzymes of the tissues. If desired, 20 percent by volume of bariumsulphate may be incorporated in the macromolecular substance, in orderto render it opaque to X-rays.

For example, the stems and the tube may be made of polypropylene.

The stems and the loop are introduced into the uterine cavity by meansof a pusher made of flexible plastics material, particular polystyrene,provided with a flat part at its upper end in order to facilitate thepositioning, as it is necessary for the stems and the loop in the formof a lily to be suitably adapted to the size of the uterine cavity inorder to ensure a sure contraceptive effect.

The invention will be more readily understood upon reading the followingdescription, with reference to the accompanying drawings, in which:

FIG. 1 shows a contraceptive device.

FIG. 2 is a section along II-II of the device of FIG. 1.

FIG. 3 shows a device similar to that of FIG. 1. The contraceptivedevice according to FIG. 1 is composed of a hollow cylinder 1 of oval orelliptic section provided with windows 2 of 1 mm by 0.37 mm and with awidened sleeve 3 with a height of 3 mm and upper diameter of 3 mm. Fourcurved stems 4 leave this sleeve, the free end 5 of each of which isfolded back on itself and is provided with a spherical excrescence and astem curved back on itself forming a loop 6, the loop having at itssummit a substantially ellipsoidal excrescence. 7. A fixing tongue 8, inthe form of an are, connected to the contraceptive device, preferablyalong the lower third of the hollow tube, is fixed to the outer edge ofthe neck at a point 9 of the periphery of the neck.

The fixing at 9 is effected by passing the tongue 8 into the neck bymeans of a needle; 2 to 3 knots are generally necessary.

The curved stems 4 are cylindrical and have a diameter of 0.5 mm, theloop 6 is also cylindrical with a diameter of 0.5 to 0.75 mm, theexcrescence 7 is 2 mm high and 4 mm long.

FIG. 3 shows a preferred contraceptive device, which differs somewhatfrom that of FIG. 1 in that one of the stems 4 of each pair of stems isintegral with a side part of the loop 6, said stems and said loop beinglocated in the same plane parallel to the axis of the hollow tube. Thecylindrical excrescence 7 has a groove on the face opposite the face ofcontact of said excrescence with the loop. The arcuate fixing tongue ofFIG. 1 is advantageously replaced here by a pastille or excrescence 8provided at the lower end of the hollow tube and intended for makingstitches on the inner edge of the opening of the uterine neck.

In general, the largest internal diametrical dimension of thecylindrical tube 1 may vary between 2 and 2.5 mm and the largest outerdiametrical dimension between 3.3 and 4 mm. The length of the tube andthe height of the stems-loop assembly intended to occupy theintra-uterine cavity depend upon the clinical examination made by thedoctor.

In fact, it is known from KNOCI-Is studies published in 1967 thatintra-uterine devices(abbreviated to I.U.D.), adaptable according to themeasurements, give better results than the standard, non-adaptabledevices, as will be seen in Table I hereinafter.

Table I Standard I.U.D. Adaptable I.U.D. Pain and bleeding I8 2.5%Expulsions l 1% 0.1% Pregnancies 6% 0 The perfect occupation of theuterine cavity ensures the contraceptive effect by triggering an earlypredecidual cytological maturation. Consequently, in order to obtain thedesired prevention, the height of the lily to be placed in the uterinecavity will depend on the measurements of the woman and will be between15 and 25mm (transfundal measurement).

Furthermore, in order to complete the prevention and the tolerance atthe level of the uterine cavity, sizes, or rathermore lengths, of tube 1should be used which differ according to the measurements of the woman.The cylindrical tube preferably has a length of between 22 and 47 mm.

The tubes intended to be lodged in the cervical part will preferably besupplied with the following four lengths: 22mm, 32mm, 37mm and 47mm. Forthe first two lengths, a Charriere gauge 10 (or French gauge 10) with aninner end diameter of 2 mm and outer end diameter of 3.3 mm. For thelast two lengths, a Charriere gauge 12 (or French gauge 12) will be usedwith an inner end diameter of 2.5 mm and outer end diameter of 4 mm.

The extreme width of the device according to the invention, inside theuterine cavity, varies between 16 and 26 mm.

I claim:

1. Contraceptive device to be placed both in the uterine cavity and inthe neck of the uterus and comprising a hollow cylindrical tube, a firstpair of supple, curved stems located in the same plane and the upperends of which are folded back in opposite directions, a second pair ofstems similar to said first pair of stems but angularly shifted withrespect thereto, and a supple stem folded back on itself, forming aloop, wherein said first and second pairs of stems and said loop arehoused, by means of their lower ends, inside said hollow cylindricaltube, intended to be place inside the neck of the uterus, which isprovided with a widening at its upper end and with one or more windowson its side wall, the pairs of stems and the loop being in planesparallel to the axis of said tube, and the loop is provided at itssummit with an excrescence substantially perpendicular to said loop.

2. Device as claimed in claim 1, wherein each of the stems of a pair ofstems is integral with a side part of the loop, the loop and the stemsto which it is connected being located in a plane parallel to the axisof the hollow tube.

3. Device as claimed in claim 1, wherein the excrescence provided at thesummit of the loop is cylindrical and provided on its upper face with adiametrical groove.

neck.

6. Device as claimed in claim 5, wherein the fixing means is a pastilleor excrescence intended to enable the stitches to be made on the inneredge of the opening of the uterine neck.

9 UNiTED STATES PATENT OFFICE CERTKFICATE 02F CORRECTION Patent No. 13,734 ,089 j Dated Ma 22 n 1973 Inventofls) R' Gaud It is FertifiQd thaterror appears in the above-idahtified patent and that said LettersPatent are hereby corrected as shown below:

Column 4, Table I:

Under "Standard I.U.D." insert --356.c:ases-- Under "Adaptable I.U.D."insert 707 cases-" Signed and sealed this 27th day of November 1973.

(SEAL) Attest:

EDWARD M.FLETCH-ER,JR. RENE. D. TEGTMEYER Attesting Office-r ActingCommlssloner of Patents

1. Contraceptive device to be placed both in the uterine cavity and inthe neck of the uterus and comprising a hollow cylindrical tube, a firstpair of supple, curved stems located in the same plane and the upperends of which are folded back in opposite directions, a second pair ofstems similar to said first pair of stems but angularly shifted withrespect thereto, and a supple stem folded back on itself, forming aloop, wherein said first and second pairs of stems and said loop arehoused, by means of their lower ends, inside said hollow cylindricaltube, intended to be place inside the neck of the uterus, which isprovided with a widening at its upper end and with one or more windowson its side wall, the pairs of stems and the loop being in planesparallel to the axis of said tube, and the loop is provided at itssummit with an excrescence substantially perpendicular to said loop. 2.Device as claimed in claim 1, wherein each of the stems of a pair ofstems is integral with a side part of the loop, the loop and the stemsto which it is connected being located in a plane parallel to the axisof the hollow tube.
 3. Device as claimed in claim 1, wherein theexcrescence provided at the summit of the loop is cylindrical andprovided on its upper face with a diametrical groove.
 4. Device asclaimed in claim 1, wherein the hollow tube is provided with aspermicidal cream or jelly with a pH of between 4.5 and
 5. 5. Device asclaimed in claim 1, wherein the hollow tube is provided with a fixingmeans at its lower part which is to be stitched near the opening of theuterine neck.
 6. Device as claimed in claim 5, wherein the fixing meansis a pastille or excrescence intended to enable the stitches to be madeon the inner edge of the opening of the uterine neck.